FDA.reportPublic FDA data

Ultrasonic lithotripsy system reusable

Definition
A slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.
GUDID devices
39
Last updated
2021-12-27 10:05:27

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04953170318818Probe for LUS-2 2.0mm O.D.OLYMPUS MEDICAL SYSTEMS CORP.MAJ-12162021-12-17
07613353001940LITHOCLASTE.M.S. Electro Medical Systems S.A.B2021-09-17
07613353001964LITHOCLASTE.M.S. Electro Medical Systems S.A.B2021-09-17
00852423006462Morpheus®PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THERTTU2021-07-22
04953170157165PROBE FOR LUS-2 2.0mm O.DOLYMPUS MEDICAL SYSTEMS CORP.MAJ-12162016-09-21
07613353002794LithoClastE.M.S. Electro Medical Systems S.A.FR-083B2016-09-01
07613353002800LithoClastE.M.S. Electro Medical Systems S.A.FR-084B2016-09-01
07613353002817LithoClastE.M.S. Electro Medical Systems S.A.FR-105B2016-09-01
07613353002824LithoClastE.M.S. Electro Medical Systems S.A.FR-106B2016-09-01
07613353002831LithoClastE.M.S. Electro Medical Systems S.A.FR-197B2016-09-01
07613353002848LithoClastE.M.S. Electro Medical Systems S.A.FR-198B2016-09-01
07613353002855LithoClastE.M.S. Electro Medical Systems S.A.FR-199B2016-09-01
07613353002862LithoClastE.M.S. Electro Medical Systems S.A.FR-200B2016-09-01
07613353002879LithoClastE.M.S. Electro Medical Systems S.A.FR-201B2016-09-01
07613353123628LITHOCLASTE.M.S. Electro Medical Systems S.A.FR-2942018-03-12
07613353123635LITHOCLASTE.M.S. Electro Medical Systems S.A.FR-2952018-03-12
07613353123642LITHOCLASTE.M.S. Electro Medical Systems S.A.FR-2962018-03-12
07613353123659LITHOCLASTE.M.S. Electro Medical Systems S.A.FR-2972018-03-12
07613353123666LITHOCLASTE.M.S. Electro Medical Systems S.A.FR-2982018-03-12
07613353123680LITHOCLASTE.M.S. Electro Medical Systems S.A.FR-3002018-03-12
00854732006041UreTron Rigid Sterile Probe 3.5 x 370 mmUltratellege USA Co., Ltd.URT-PR-3.5-370S2016-09-01
00854732006058UreTron Rigid Sterile Probe 3.5 x 430mmUltratellege USA Co., Ltd.URT-PR-3.5-430S2016-09-01
00854732006065UreTron Rigid Sterile Probe 3.1 x 430 mmUltratellege USA Co., Ltd.URT-PR-3.1-430S2016-09-01
00854732006072UreTron Semi Rigid Sterile Probe 1.9 x 370 mmUltratellege USA Co., Ltd.URT-PS-1.9-370S2016-09-01
00854732006089UreTron Semi Rigid Sterile Probe 1.9 x 570 mmUltratellege USA Co., Ltd.URT-PS-1.9-570S2016-09-01
00854732006096UreTron Semi Rigid Sterile Probe 1.5 x 270 mmUltratellege USA Co., Ltd.URT-PS-1.5-270S2016-09-01
00854732006102UreTron Semi Rigid Sterile Probe 1.5 x 370 mmUltratellege USA Co., Ltd.URT-PS-1.5-370S2016-09-01
00854732006119UreTron Semi Rigid Sterile Probe 1.5 x 480 mmUltratellege USA Co., Ltd.URT-PS-1.5-480S2016-09-01
00854732006126UreTron Semi Rigid Sterile Probe 1.5 x 570 mmUltratellege USA Co., Ltd.URT-PS-1.5-570S2016-09-01
00854732006140UreTron Semi Rigid Sterile Probe 1.3 x 370 mmUltratellege USA Co., Ltd.URT-PS-1.3-370S2016-09-01
00854732006157UreTron Semi Rigid Sterile Probe 1.3 x 570mmUltratellege USA Co., Ltd.URT-PS-1.3-570S2016-09-01
00854732006164UreTron Semi Rigid Sterile Probe 1.0 x 270 mmUltratellege USA Co., Ltd.URT-PS-1.0-270S2016-09-01
00854732006171UreTron Semi Rigid Sterile Probe 1.0 x 480 mmUltratellege USA Co., Ltd.URT-PS-1.0-480S2016-09-01
00854732006188UreTron Semi Rigid Sterile Probe 1.0 x 570 mmUltratellege USA Co., Ltd.URT-PS-1.0-570S2016-09-01
00854732006195UreTron Flexible Sterile Probe 0.8 x 600 mmUltratellege USA Co., Ltd.URT-PF-0.8-600S2016-09-12
00854732006201UreTron Flexible Sterile Probe 0.8 x 1200 mmUltratellege USA Co., Ltd.URT-PF-0.8-1200S2016-09-12
00854732006294UreTron Flexible Sterile ProbeUltratellege USA Co., Ltd.URT-PF-0.8-1370S2016-09-12
00854732006300UreTron Flexible Sterile ProbeUltratellege USA Co., Ltd.URT-PF-0.8-920S2016-09-12
10854732006031UreTron Rigid Sterile Probe 3.1 x 370mm MED-SONICS CORPORATIONURT-PR-3.1-370S2016-09-01